Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma (CREON2000A)

A Double Blind, Randomized, Sham Controlled Trial to Investigate the Effect of the CREON2000A on Asthma Control in Children With Mild to Moderate Persistent Asthma

This is a pivotal, 12-month, randomized, sham controlled, parallel group, multicenter, double blind study with an allocation ratio of 1:1. The study population is children between the ages 6 to 17 years, with mild to moderate persistent asthma. The purpose of the study is to determine whether the CREON2000A, an environmental control device, will decrease asthma severity, as measured by the Composite Asthma Severity Index (CASI), in children with mild to moderate persistent allergic asthma over a twelve month period.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: CREON2000A

Detailed Description

The pilot study (Protocol #PA-01-052; Health Effects of CREON2000 in Asthmatic Children. IB ID# GI 1001) offered preliminary evidence that the CREON2000A system may be beneficial in asthma. This study is a follow-up, using children, aged 6 to 17 with mild to moderate persistent asthma, as the subjects of the study. Children are usually treated with fewer controller medications and have fewer confounding co-morbidities making it more likely to detect a therapeutic benefit from an environmental intervention. The study will involve 4 study site visits, 2 home visits, and 7 phone calls. Adjustment of asthma therapy by the site clinician will occur at baseline (Visit 1) and at each follow-up office visit after Visit 1 using a modified algorithm based on the National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines. Enrollment will be over 18 months. The study duration for each subject will be 12 months.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Homestead, Florida, United States, 33030
      • Advanced Research Institute of Miami, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Allergy & Asthma Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center, LLC
    • Columbus, Ohio, United States, 43205
      • Columbus Nationwide Children's Hospital
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Assn.
    • Toledo, Ohio, United States, 43560
      • Toledo Institute of Clinical Research
    • Willoughby, Ohio, United States, 44094
      • Great Lakes Medical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

1. Males and Females ages 6.0 to 17.0 years.
2. Subjects with a physician diagnosis of mild or moderate persistent asthma.
3. FEV1 ≥ 60% predicted with ≥ 12% improvement after bronchodilator therapy.
4. Must have evidence of; 1) serum specific IgE (immunocap) ≥ .35 or 2) a positive skin prick test to one or more common indoor allergens including standardized house dust mite, cat, dog, cockroach, mouse in the past.

Exclusion criteria

1. Current smokers
2. Passive exposure to environmental tobacco smoke at home or active fireplaces and other sources of air particulates (wood burning stoves, kerosene heaters) at home.
3. Diagnosed by a physician with a chronic lung disease other than asthma.
4. Upper or lower respiratory infection within four weeks prior to enrollment.
5. Known to have any other chronic illness (besides asthma) that is not well controlled at the time of screening (Visit 1).
6. History of a life threatening asthma attack requiring cardiopulmonary support, intubation with ventilatory support, hospitalization in an intensive care unit or hospitalization for asthma within 6 months preceding study screening (Visit 1).
7. Participation in another investigational drug/device study within the past 3 months (not including chart or observational studies)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device: CREON2000A; Children with mild to moderate asthma maintains allergy medicines have an experimental ultra violet device installed in their homes.	Device: CREON2000A
Sham Comparator: Device: Sham Comparator; Children with mild to moderate asthma maintains allergy medicines have a sham device using a shielded blue light sham lamp that otherwise resembles the experimental device installed in their homes.	Device: CREON2000A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CASI Score	Difference between study arms in the change in asthma severity as measured by the Composite Asthma Severity Index (CASI) from Baseline (Visit 1) to the 12-month follow up office visit	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Forced Expiratory Volume (FEV1)	• in the mean change in FEV1 (% predicted) from Baseline (Visit 1) to 12-month follow up office visit	Baseline and 12 months
Mean change in number of day time symptom scores	• in the mean change in number of day time symptom scores from Baseline (Visit 1) to the 4, 8 and 12-month follow up office visits	Baseline, 4, 8 and12 months
Mean change in number of night time symptoms	• in the mean change in number of night time symptom scores from Baseline (Visit 1) to the 4, 8 and 12-month follow up office visits	Baseline, 4, 8 and 12 months
Mean change in the number of daily puffs/inhalations of short-acting beta-agonist (SABA) rescue medication	• in the mean change in the number of daily puffs/inhalations of short-acting beta-agonist rescue medication taken over 14 days prior to each evaluation, from Baseline (Visit 1) to 4, 8 and 12 month follow up office visits	Baseline, 4, 8 and 12 months
Mean Change in CASI	• in the mean change in CASI from Baseline (Visit 1) to 4- and 8- and 12-month follow up office visits	Baseline, 4, 8 and 12 months
Mean change in daily does of inhaled glucocorticoids taken (µg/day)	• in the mean change in daily dose of inhaled glucocorticoids taken (µg/day) by participants from Baseline (Visit 1) to 4, 8 and 12 months follow up office visits.	Baseline 4, 8 and 12 months
Mean change in the percentage of patients with an asthma exacerbation	• in the mean change in the percentage of patients with an asthma exacerbation during the period from baseline (Visit 1) to the 12 month follow up office visit	Baseline and12 months

Collaborators and Investigators

• Sponsor: General Innovations and Goods, Inc.
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of Cincinnati; Bernstein Clinical Research Center
• Investigators: Study Chair: Jonathan Bernstein, MD, University of Cincinnati, Cincinnati, Ohio; Principal Investigator: Mark Glazman, PhD, General Innovations and Goods, Inc. (GI&G)

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2016
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 16, 2016
• First Posted (Estimate): March 22, 2016

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: asthma environment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: U44-CRE-01; U44AI074918 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED